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A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG


Phase 4
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG


Inclusion Criteria:



- Patients must give written (personally signed and dated) informed consent before
completing any study related procedure.

- Patients must be 18 years old or over.

- Patients must have a documented diagnosis of locally advanced or metastatic prostate
cancer suitable for hormonal treatment

- Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL

- Patients must have received at least two injections of a 3- monthly LHRH agonist by
the time of the screening tests

- Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels
between screening and baseline (i.e. the baseline value must either be lower or less
than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the
screening value).

In addition:

- For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any
formulation) must have been initiated within the last 3 years from Baseline,

- For patients with metastatic prostate cancer (M+) and a Gleason score

≤ 7, LHRH agonist injection (any formulation) must have been initiated within the
last 2 years from Baseline,

- For patients with metastatic prostate cancer (M+) and a Gleason score > 7, LHRH
agonist injection (any formulation) must have been initiated within the last 12
months from Baseline.

- Patients must have an estimated life expectancy of at least twelve months according
to the investigator's assessment.

Exclusion Criteria:

- Patients will not be included in the study if:

- Patients have had previous surgical castration.

- Patients are, in the opinion of the investigator, unable to comply fully with the
protocol and the study instructions.

- Patients have received investigational drug(s) or treatment(s) within 30 days prior
to study entry or will require a concurrent treatment with any other experimental
drugs or treatments.

- Patients have had a diagnosis of any other cancer without a history of
stability/remission within five years of screening, with the exception of
non-metastatic basal cell carcinoma.

- Patients currently taking additional anti-androgen therapy as part of an active
hormonal control therapy.

- Patients scheduled to receive palliative radiotherapy during the course of the study.

- Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to
radiotherapy.

- Patients receiving LHRH agonist as adjuvant to surgery.

- Patients scheduled to undergo radical prostatectomy during the course of the study.

- Patients with known hypersensitivity to LHRH agonists, their analogues or any or any
other component of the products to be administered.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in the percentage of participants who maintain biochemical castration

Outcome Description:

A difference of less than 7.5% between the two treatment arms is considered to be not clinically relevant.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Anne Fairey, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

A-97-52014-181

NCT ID:

NCT01673984

Start Date:

August 2012

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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